UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Common carotid artery blood flow during general anesthesia
Title of the study (Brief title)	Common carotid artery blood flow during general anesthesia
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the relationship between common carotid artery blood flow and blood pressure, between the flow and cardiac output during one lung ventilation.
Basic objectives2	Others
Basic objectives -Others	relation with duration of one lung ventilation time
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	peak systolic velocity, end diastolic velocity and time averaged maximum velocity
Key secondary outcomes	systemic blood pressure and cardiac output

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1)lobectomy 2)ASA PS 1 or 2
Key exclusion criteria	1)emergency operation 2)ASA PS over 3 3)patient history of stroke or carotid stenosis
Target sample size	30

Research contact person
Name of lead principal investigator	Soichiro Inoue
Organization	St. Marianna University School of Medicine
Division name	Department of Anesthesia
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan
TEL	044-977-8111
Email	inoues@marianna-u.ac.jp

Public contact
Name of contact person	Eriko Amano
Organization	St. Marianna University School of Medicine
Division name	Department of Anesthesia
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan
TEL	044-977-8111
Homepage URL
Email	e2amano@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine Department of Anesthesia
Institute
Department

Funding Source
Organization	St. Marianna University School of Medicine Department of Anesthesia
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	聖マリアンナ医科大学病院

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 26 Day
Anticipated trial start date	2017 Year 04 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 08 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	n.p.

Management information
Registered date	2017 Year 11 Month 13 Day
Last modified on	2018 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034220